Attention UGA Research Community
Join Office for Human Research Protections (OHRP) staff at a Research Community Forum called “Navigating a River of Change: Bringing Research Up to Par” in Augusta, GA, July 18-19, 2017. The workshop will feature interactive presentations by OHRP staff on a range of topics related to the HHS regulations, including discussion of the revised Common Rule. The conference will include break-out sessions covering a variety of research topics such as central IRBs and related issues, genetics research, online consent, and reporting concerns. Connect with human research professionals from across the country and learn about the regulations directly from OHRP staff—don’t miss out! This event is co-sponsored by UGA.
Register at: http://www.augusta.edu/research/dhhs/
Quality Improvement Program
Feedback wanted: The Human Subjects Office (HSO) has developed a Quality Improvement Program (QIP) to assess and respond to challenges with the administration, review, and conduct of human subjects research. The primary purpose of the QIP is to increase the quality, performance, and efficiency of UGA’s Human Subjects Protection Program (HRPP).
The QIP will include three components or stages: 1) Quality Assurance, 2) Quality Improvement, and 3) Continuous Quality Improvement. We are focused on finding ways we can become more effective at protecting subjects while also becoming more efficient. Our goal is an HRPP that is not only proactive, but interactive, and emphasizes prevention of harm. Please visit the following webpage for updates about this new program as it is implemented across UGA: http://research.uga.edu/hso/quality-improvement-program/
How Do I Report an Adverse Event?
The Principal Investigator (PI) bears direct responsibility for the implementation and conduct of the research and for ensuring the protection of human research participants. The PI must promptly report any unanticipated problems or incidents involving risks to subjects or others to the IRB.
Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious (see below), must be reported to the IRB by submitting a Report of New Information in the e-portal (irb.ovpr.uga.edu) within 72 hours of any member of the investigative team becoming aware of the event. You also should notify the chair of the department.
If you have any questions, please contact the HSO at 542-3199.